NCT03087227: NEUTROSIS

Shared Health Information System for Febrile Neutropenia

Completed NA Last updated 9 May 2022

What this trial tests

NA trial testing NEUTROSIS in Febrile Neutropenia in 121 participants. Completed in 20 October 2019.

Timeline

22 February 2017

Primary endpoint
20 October 2019

20 October 2019

Quick facts

Lead sponsor	Marie-Helene METZGER
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	121
Start date	22 February 2017
Primary completion	20 October 2019
Estimated completion	20 October 2019
Sites	3 locations across France

Drugs / interventions tested

• NEUTROSIS

Conditions studied

• Febrile Neutropenia — all drugs for Febrile Neutropenia →
• Solid Tumor — all drugs for Solid Tumor →
• Hematologic Neoplasms — all drugs for Hematologic Neoplasms →

Sponsor

Marie-Helene METZGER

Who can join

18 and older, any sex, with Febrile Neutropenia or Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The use of e-health in improving the quality of health services is a rapidly expanding research area, in particular its usefulness in patient management of the home-hospital care pathway. Febrile neutropenia is a serious and frequent complication of cytotoxic chemotherapy and better identification of low-risk patients who can be treated at home could be made possible by these technologies.

The objective of this study is to evaluate a shared health information system (NEUTROSIS) for home-hospital management of febrile neutropenia after anti-tumor chemotherapy. The study aims to compare the average length of hospital stay for febrile neutropenia among patients receiving NEUTROSIS and those receiving standard care

Materials and methods A shared information system (NEUTROSIS) has been developed to connect a smartphone web application for the patient to the existing shared medical record of the Paris Sud hospital group (AP-HP, France - 4D software).

The study consists of conducting a randomized controlled trial to compare a cohort of patients receiving cytotoxic chemotherapy for solid cancer or heamatological malignancies using the NEUTROSIS shared information system (n=100) and a cohort of patients followed by the hospital's standard care over a treatment period of six months (n=100). During the 15 days following each chemotherapy cycle, the 2 groups of patients must take their temperature daily. Both groups are trained like any patient under chemotherapy to contact the team in case of fever. The NEUTROSIS group captures daily its temperature and the occurrence of other symptoms on the smartphone application. This information is then transmitted instantly to the hospital care team who will be alerted in case of fever and will contact the patient. The control group will indicate these same data in a paper diary and will have to contact the health team in case of fever as done in the usual care.

The two groups of patients will be followed 6 months through a questionnaire asked to the patient at each hospital visit for chemotherapy cycle. The questionnaire collects information on the occurrence of symptoms and healthcare use between two chemotherapy cycles. A last follow-up questionnaire is asked by phone at the endpoint follow-up (6 months). The study will take place in two hospital sites of the Paris University hospital (A Béclère and Kremlin-Bicètre).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.